CARsgen Therapeutics and Huadong Medicine Unveil Revolutionary Cancer Treatment: Zevorcabtagene Autoleucel Now Available in China

CARsgen Therapeutics Holdings Limited (2171.HK) and Huadong Medicine (Hangzhou) Co., Ltd., a subsidiary of Huadong Medicine Co., Ltd. (SZ: 000963), have joined forces in an exciting venture to bring CARsgen’s BCMA CAR-T product CT053 to mainland China. This innovative CAR T-cell therapy has the potential to revolutionize the treatment of hematologic malignancies and solid tumors.

In October 2022, CARsgen’s lead drug candidate, zevorcabtagene autoleucel (“zevor-cel”), a revolutionary autologous CAR T-cell product treating relapsed/refractory multiple myeloma ,will have its New Drug Application (NDA) submitted to the National Medical Products Administration (NMPA). With its powerful commercial capabilities and broad network, Huadong Medicine was granted the exclusive right to commercialize zevor-cel in mainland China – marking a major milestone in the fight against R/R MM.

CARsgen Therapeutics Holdings Limited is proud to announce a strategic and mutually beneficial partnership with Huadong Medicine, a leader in the oncology therapeutic area. With Huadong’s extensive commercialization experience in mainland China, CARsgen hopes to enhance the successful commercialization of Zevor-cel, a differentiated BCMA CAR T cell therapy, which has shown promising data in clinical programs and is now under NDA priority review by NMPA. Despite recent advancements, there remain significant unmet medical needs for the treatment of multiple myeloma, and this collaboration offers an opportunity to help fill them.

Huadong Medicine is thrilled to work with leading biotech company CARsgen to commercialize CT053, a revolutionary cell therapy for cancer patients. With integrated R&D and manufacturing capabilities, this groundbreaking treatment has the potential to drastically improve the survival and quality of life of patients with relapsed/refractory multiple myeloma. Leveraging Huadong’s extensive hematology expertise and commercial presence in China, we are excited to bring CT053 to more patients and make a difference in their lives.

CARsgen has reached an agreement to receive an impressive RMB200 million upfront payment, and is eligible for even greater regulatory and commercial milestone payments up to a staggering RMB1,025 million. The company will stay firmly in the driver’s seat, being responsible for the development, regulatory approval and manufacturing of CT053 in mainland China.

About CT053

CT053, otherwise known as zevor-cel, is an exciting new autologous BCMA CAR T-cell product candidate for the treatment of relapsed/refractory multiple myeloma. Following a successful New Drug Application based on the phase I/II data from LUMMICAR STUDY 1 in China, the product is now being evaluated in North America in the phase 1b/2 LUMMICAR STUDY 2. Furthermore, further clinical trials are being planned to explore the potential of CT053 for earlier line multiple myeloma treatment.

CT053 has been recognized by both the U.S. FDA and the European Medicines Agency (EMA) as a groundbreaking therapy, with the former awarding it with Regenerative Medicine Advanced Therapy (RMAT) and Orphan Drug designations in 2019, and the latter bestowing it with Priority Medicines (PRIME) and Orphan Medicinal Product designations in 2019 and 2020 respectively. The NMPA has also granted CT053 with its Breakthrough Therapy designation in 2020.

About CARsgen Therapeutics Holdings Limited

CARsgen is on a mission to make cancer curable by harnessing the power of innovative CAR T-cell therapies. With operations in both China and the U.S., the Company has developed an integrated cell therapy platform with in-house capabilities that span target discovery, antibody development, clinical trials, and commercial-scale manufacturing. CARsgen has also developed novel technologies and a product pipeline with global rights to improve the safety profile, enhance the efficacy in treating solid tumors, and reduce treatment costs. By bringing these cutting-edge cell therapies to cancer patients worldwide, CARsgen is well on its way to becoming a global biopharmaceutical leader.

About Huadong Medicine

Huadong Medicine Co., Ltd., a leading large-scale comprehensive pharmaceutical listed company based in Hangzhou, China, is driven by its commitment to providing the best care to its patients. Founded in 1993, Huadong Medicine has 12,000 employees and offers a full range of services, from research and development to manufacturing, distribution, sales, and marketing, with a focus on oncology, immunology, nephrology, and diabetes. Huadong Medicine is dedicated to making a difference in the lives of those it serves, and its motto is ‘Patient Centered, Science Driven.’

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